Dr Reddy’s receives DCGI’s approval to conduct clinical trial for Sputnik V vaccine in India

Dr Reddy's has received the permission from the Drug Controller General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for the Sputnik V vaccine in India. This is the vaccine developed by the Russia's Gamaleya Institute and funded by Russian Development Investment Fund (RDIF). The multi-center and randomized controlled study, which will include safety and immunogenicity study.

In September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India.

Sputnik V is currently undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week.

This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic, said G V Prasad, Managing Director, Dr. Reddy’s Laboratories in a press statement.